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/R E P E A T -- Canadian Global RE-LY(R) Trial Co-ordinated out of McMaster University Demonstrates Convincingly that PRADAX(R) (dabigatran etexilate) is Superior in Stroke Reduction with Less Bleeding Compared to Warfarin/

Results of the largest trial of its kind with over 18,000 atrial
fibrillation patients published in the New England Journal of Medicine(1)
TORONTO, Aug. 30 /CNW/ - Results of the landmark RE-LY(R) Trial
(Randomized Evaluation of Long term anticoagulant therapy) demonstrate that
atrial fibrillation (AF) patients taking PRADAX(R) (dabigatran etexilate)
150mg twice daily (BID) significantly reduced their risk of stroke and
systemic embolism by 34 per cent (p less than 0.001) as compared to patients
well-controlled on warfarin, without increasing the risk of major bleeding.
PRADAX(R) 110mg BID demonstrated similar reductions in stroke and
systemic embolism compared to well-controlled warfarin while delivering a
significant 20 per cent reduction (p=0.003) in major bleeding rates compared
to warfarin.
Similarly positive results were also demonstrated in key secondary and
other outcomes, including a 15 per cent reduced risk of death due to vascular
mortality with the 150mg BID dose (p= 0.04) and a superior reduction in
hemorrhagic strokes with both 150mg and 110mg BID doses, reducing risk by 74
per cent and 69 per cent respectively (p less than 0.001 and p less than
0.001). For safety, both doses showed a superior reduction in life
threatening, intracranial and total bleeding. As importantly, these benefits
occurred without hepatoxicity.
"The results of dabigatran in RE-LY(R) exceeded all our expectations. We
now have an oral treatment which offers superior protection from stroke with
less bleeding and without the need for routine monitoring. In addition to
protecting patients from strokes, we as physicians are especially concerned
about life threatening or disabling bleeding with warfarin due to its narrow
therapeutic window. On top of the efficacy, dabigatran has shown equally
impressive safety results, offering a wider safety margin," commented
Professor Stuart Connolly, co-principal investigator of RE-LY(R) and Director,
Division of Cardiology at The Population Health Research Institute, McMaster
University, Hamilton, Canada.
According to the Heart and Stroke Foundation of Canada, 250,000 Canadians
currently diagnosed with AF are at least five times more at risk of having a
stroke and twice as likely to die from one. In Canada, stroke is the third
leading cause of death with up to 15 per cent of strokes being caused by AF.
This number increases to one-third of all strokes for those over the age of
60(2).
"For over 50 years, physicians have had to treat patients in this area
with medications, such as warfarin, that have imposed challenging restrictions
on their patients," says Dr. Christian Constance, Cardiologist and RE-LY(R)
Trial Investigator, University of Montreal, Maisonneuve-Rosemont Hospital. "It
is exciting to see a new option that eliminates the need for lifelong blood
tests, dose adjustments and the numerous food and drug interactions, while
giving patients a considerably greater reduction of their risk of stroke."
"With the robust results from RE-LY(R) dabigatran etexilate, a compound
from our own research and development, can revolutionize anticoagulant
treatment for physicians and patients," commented Dr Andreas Barner, the
chairman of the Board of Managing Directors of Boehringer Ingelheim. "We look
forward to expeditiously submitting these results to regulatory authorities
around the world so that new options can be made available for millions of
patients with atrial fibrillation at risk of stroke."
These trial results will shortly be submitted by Boehringer Ingelheim
(Canada) Limited to Health Canada seeking approval of PRADAX(R) in the AF
indication. Upon approval the product will be available to Canadians.
RE-LY(R): The largest AF outcome trial to date(1),(3)
RE-LY(R) (Randomized Evaluation of Long term anticoagulant therapy) is a
global, phase III, randomized trial of 18,113 patients, including 1,150
Canadian patients, enrolled in over 900 centres in 44 countries, including 52
centres in Canada, investigating whether dabigatran etexilate (2 blinded
doses) is as effective as well-controlled warfarin - INR 2.0-3.0 - (open
label) for stroke prevention. Patients with non-valvular AF and at least one
other risk factor for stroke (i.e., previous ischemic stroke, transient
ischemic attack, or systemic embolism, left ventricular dysfunction, age 75
years, age 65 years with either diabetes mellitus, history of coronary artery
disease, or hypertension) were enrolled in the study for 2 years with a
minimum of 1 year follow-up.
The primary endpoint of the trial was incidence of stroke (including
haemorrhagic) and systemic embolism. Secondary outcome measures included all
cause death, incidence of stroke (including hemorrhagic), systemic embolism,
pulmonary embolism, acute myocardial infarction and vascular death (including
death from bleeding). Additional safety endpoints included major and minor
bleeding events, intracranial bleeding, intracerebral haemorrhage, elevations
in liver transaminases, bilirubin and hepatic dysfunction.
The statistical design of the study allowed for a testing of superiority
to the comparator once the requirement of non-inferiority was established.
The RE-LY(R) Trial is led by Co-Chairmen Dr. SalimYusuf, Professor of
Epidemiology and Cardiology, Population Health Research Institute McMaster
University, Hamilton, Canada and Dr. Lars Wallentin, Professor of Cardiology
and Director of the Uppsala University, Sweden. Co-principal investigators for
the trial are Dr. Stuart Connolly, Professor of Medicine and Director,
Division of Cardiology, McMaster University, Hamilton, Canada and Dr Michael
Ezekowitz, Vice President and Professor, Lankenau Institute for Medical
Research, Wynnewood, PA, USA. Population Health Research Institute in
Hamilton, Ontario Canada independently managed the database and performed the
primary data analysis.
About AF and stroke
Atrial fibrillation, a type of irregular heart rhythm known as an
arrhythmia, can cause the heart to beat very fast, sometimes more than 150
beats per minute. While it is rare in people under 40, its prevalence
increases with age(2). After the age of 55, the incidence of AF doubles with
each decade of life and with other risk factors for heart disease and stroke
including high blood pressure, diabetes and underlying heart disease(2).
Strokes due to AF tend to be severe, with an increased likelihood of death (20
per cent) and disability (60 per cent), with resultant societal costs and
burden to the healthcare system(4).
About PRADAX(R) (dabigatran etexilate)
PRADAX(R) is at the forefront of a new generation of oral anticoagulants
- direct thrombin inhibitors (DTIs) - targeting a high unmet medical need in
the prevention and treatment of acute and chronic thromboembolic diseases.
PRADAX(R) has already been approved and is widely utilized in over 40
countries for the primary prevention of venous thromboembolic events (blood
clots) in adults who have undergone elective total hip or elective total knee
replacement surgery.
About RE-VOLUTION(R)
RE-LY(R) is part of Boehringer Ingelheim's extensive RE-VOLUTION(R)
clinical trial program - evaluating the efficacy and safety of dabigatran
etexilate against current standard therapy in over 38,000 patients.
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About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading
pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates
globally with 138 affiliates in 47 countries and 41,300 employees. Since it
was founded in 1885, the independent, family-owned company has been committed
to researching, developing, manufacturing and marketing novel products of high
therapeutic value for human and veterinary medicine.
In 2008, Boehringer Ingelheim posted net sales of 11.6 billion euro while
spending one fifth of net sales in its largest business segment Prescription
Medicines on research and development.
For further information please visit www.boehringer-ingelheim.com
References
1. Connolly SJ, Ezekowitz MD, Yusuf S. Dabigatran versus Warfarin in
Patients with Atrial Fibrillation. N Eng J Med 2009; 361. Published
online 30 Aug 2008
2. Heart and Stroke Foundation of Canada. 2009 Stroke Report Card. http://www.heartandstroke.com/site/apps/nlnet/content2.aspx?c=ikIQLcMWJtE&amp;b=4955951&amp;ct=7085089&amp;src=report
(Accessed August 25, 2009)
3. Ezekowitz MD, Connolly S, Parekh A, et al. Rationale and design of
RE-LY: Randomized evaluation of long-term anticoagulant therapy,
warfarin, compared with dabigatran. Am Heart J 2009;157: 805-10
4. Lin HJ, Wolf PA, Kelly-Hayes M, et al. Stroke severity in atrial
fibrillation: the Framingham study. Stroke 1996;27:1760-4